Alicia Huerta

The association between asthma control, health care costs, and quality of life in France and Spain

BackgroundCurrent asthma management guidelines are based on the level of asthma control. The impact of asthma control on health care resources and quality of life (QoL) is insufficiently studied. EUCOAST study was designed to describe costs and QoL in adult patients according to level of asthma control in France and Spain.MethodsAn observational cost of illness study was conducted simultaneously in both countries among patients age greater or equal to 18 with a diagnosis of asthma for at least 12 months. Patients were recruited prospectively by GPs in 2010 in four waves to avoid a seasonal bias. Health care resources utilization of the three months before the inclusion was collected through physician questionnaires. Asthma control was evaluated using 2009 GINA criteria over a 3-month period. QoL was assessed using EQ-5D-3L®.Results2,671 patients (France: 1,154; Spain: 1,517) were enrolled. Asthma was controlled in 40.6% [95% CI: 37.7% - 43.4%] and 29.9% [95% CI: 27.6% - 32.3%] of French and Spanish patients respectively.For all types of costs, the percentage of patients using health care resources varied significantly according to the level of asthma control. The average cost (euros/3-months/patient) of controlled asthma was €85.4 (SD: 153.5) in France compared with €314.0 (SD: 2,160.4) for partially controlled asthma and €537.9 (SD: 2,355.7) for uncontrolled asthma (p<0.0001). In Spain, the corresponding figures were €152.6 (SD: 162.1), €241.2 (SD: 266.8), and €556.8 (SD: 762.4). EQ-5D-3L® score was higher (p<0.0001) in patients with controlled asthma compared to partially controlled and uncontrolled asthma in both countries (respectively 0.88; 0.78; 0.63 in France and 0.89; 0.82; 0.69 in Spain).ConclusionsIn both countries, patients presenting with uncontrolled asthma had a significantly higher asthma costs and lower scores of Qol compared to the others.

Generic utilities in Chronic Obstructive Pulmonary disease patients stratified according to different staging systems

BackgroundTo determine generic utilities for Spanish chronic obstructive pulmonary disease (COPD) patients stratified by different classifications: GOLD 2007, GOLD 2013, GesEPOC 2012 and BODEx index.MethodsMulticentre, observational, cross-sectional study. Patients were aged ≥40 years, with spirometrically confirmed COPD. Utility values were derived from EQ-5D-3 L. Means, standard deviations (SD), medians and interquartile ranges (IQR) were computed based on the different classifications. Differences in median utilities between groups were assessed by non-parametric tests.Results346 patients were included, of which 85.5% were male with a mean age of 67.9 (SD = 9.7) years and a mean duration of COPD of 7.6 (SD = 5.8) years; 80.3% were ex-smokers and the mean smoking history was 54.2 (SD = 33.2) pack-years. Median utilities (IQR) by GOLD 2007 were 0.87 (0.22) for moderate; 0.80 (0.26) for severe and 0.67 (0.42) for very-severe patients (p < 0.001 for all comparisons). Median utilities by GOLD 2013 were group A: 1.0 (0.09); group B: 0.87 (0.13); group C: 1.0 (0.16); group D: 0.74 (0.29); comparisons were statistically significant (p < 0.001) except A vs C. Median utilities by GesEPOC phenotypes were 0.84 (0.33) for non exacerbator; 0.80 (0.26) for COPD-asthma overlap; 0.71 (0.62) for exacerbator with emphysema; 0.72 (0.57) for exacerbator with chronic bronchitis (p < 0.001). Comparisons between patients with or without exacerbations and between patients with COPD-asthma overlap and exacerbator with chronic bronchitis were statistically-significant (p < 0.001). Median utilities by BODEx index were: group 0–2: 0.89 (0.20); group 3–4: 0.80 (0.27); group 5–6: 0.67 (0.29); group 7–9: 0.41 (0.31). All comparisons were significant (p < 0.001) except between groups 3–4 and 5–6.ConclusionIrrespective of the classification used utilities were associated to disease severity. Some clinical phenotypes were associated with worse utilities, probably related to a higher frequency of exacerbations. GOLD 2007 guidelines and BODEx index better discriminated patients with a worse health status than GOLD 2013 guidelines, while GOLD 2013 guidelines were better able to identify a smaller group of patients with the best health.

Manejo asistencial del paciente con hiperplasia benigna de próstata en España

OBJECTIVES To identify clinical management of benign prostatic hyperplasia (BPH) in Spain and its associated health care resources. MATERIAL AND METHODS A qualitative cross-sectional study was conducted through telephone interviews to general practitioners (GP) and urologists. Information about diagnosis, pharmacologic treatment and follow-up was collected. Results were clustered according to the key variables considered as drivers of clinical practice patterns: BPH diagnosis, severity classification, treatment initiation and follow up of patients. RESULTS 153 GP and 154 urologists participated in the study. 7 different clinical patterns were identified in primary care (PC). Resource use during diagnosis is relatively homogeneous, reporting a range of 2.0 to 2.6 visits employed and being the most frequent test performed PSA and urine test. Follow-up is heterogeneous; frequency of follow-up visits oscillates from 3.2 to 7.0 visits/patient/year and type of tests performed is different among patterns and within the same pattern. In Urology, 3 clinical patterns were identified. Resource use is homogeneous in the diagnosis and in the follow-up; urologists employed 2 visits in diagnosis and a range of 2.1 to 3.2 visits/patient/year in the follow-up. The most frequent tests both in diagnosis and follow-up are PSA and digital test. CONCLUSIONS BPH management shows variability in PC, identifying 7 different clinical practice patterns with different resource use during the follow-up among patterns and within the same pattern. The implementation of clinical guidelines could be justified to reduce heterogeneity.

Cost-Effectiveness of the Combination Therapy of Dutasteride and Tamsulosin in the Treatment of Benign Prostatic Hyperlasia in Spain

Abstract Objective To evaluate the incremental cost-effectiveness ratio (ICER) of the combination therapy with dutasteride and tamsulosin (DUT+TAM) as initiation treatment versus the most used drug in Spain, tamsulosin (TAM), in the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) with risk of progression. Methods A semi-Markov model was developed using 4-year and 35-year time horizons and from the Spanish National Healthcare Service perspective. Data was obtained from the CombAT trial. Effectiveness was measured in terms of quality adjusted life years (QALYs). An experts’ panel defined healthcare resources and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in PTP WAT ; in the case of TAM, the generic price is used; in the case of DUT+TAM the price of a fixed-dose combination is used. Costs are expressed in 2010 Euros. Results Combination therapy with DUT+TAM produces an incremental effectiveness of 0.06QALY at year 4 and 0.4QALY at year 35. DUT+TAM represents an incremental cost of €810.53 at 4 years and €3,443.62 at 35 years. Therefore, the ICER for DUT+TAM versus TAM is €14,023.32/QALY at year 4 and €8,750.15/QALY at year 35. Conclusions Initiation treatment with DUT+TAM represents a cost-effective treatment versus TAM, the most used treatment in Spain, due to the fact the ICER is below the threshold that usually allows a technology to be considered as cost-effective.

Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic COPD Spanish patients

Purpose Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective. Methods A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed. Results UMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY. Conclusion UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.

Clinical variables impacting on the estimation of utilities in chronic obstructive pulmonary disease.

Purpose Health utilities are widely used in health economics as a measurement of an individual’s preference and show the value placed on different health states over a specific period. Thus, health utilities are used as a measure of the benefits of health interventions in terms of quality-adjusted life years. This study aimed to determine the demographic and clinical variables significantly associated with health utilities for chronic obstructive pulmonary disease (COPD) patients. Patients and methods This was a multicenter, observational, cross-sectional study conducted between October 2012 and April 2013. Patients were aged ≥40 years, with spirometrically confirmed COPD. Utility values were derived from the preference-based generic questionnaire EQ-5D-3L applying weighted Spanish societal preferences. Demographic and clinical variables associated with utilities were assessed by univariate and multivariate linear regression models. Results Three hundred and forty-six patients were included, of whom 85.5% were male. The mean age was 67.9 (standard deviation [SD] =9.7) years and the mean forced expiratory volume in 1 second (%) was 46.2% (SD =15.5%); 80.3% were former smokers, and the mean smoking history was 54.2 (SD =33.2) pack-years. Median utilities (interquartile range) were 0.81 (0.26) with a mean value of 0.73 (SD =0.29); 22% of patients had a utility value of 1 (ceiling effect) and 3.2% had a utility value lower than 0. The factors associated with utilities in the multivariate analysis were sex (beta =-0.084, 95% confidence interval [CI]: −0.154; -0.013 for females), number of exacerbations the previous year (−0.027, 95% CI: −0.044; -0.010), and modified Medical Research Council Dyspnea Scale (mMRC) score (−0.123 [95% CI: −0.185; −0.061], −0.231 [95% CI: −0.301; −0.161], and −0.559 [95% CI: −0.660; −0.458] for mMRC scores 2, 3, and 4 versus 1), all P<0.05. Conclusion Multivariate analysis showed that female sex, frequent exacerbations, and an increased level of dyspnea were the main factors associated with reduced utility values in patients with COPD.

Cost-Effectiveness Of Umeclidinium/Vilanterol In Symptomatic Copd Spanish Patients

Sensitivity analysis ● In the deterministic sensitivity analysis the ICER ranged between 20,636 and 47,428 €/QALY. The parameters with the greatest impact were the modification of the utility values, the difference in efficacy between treatments and the time horizon (Figure 2). ● In the probabilistic sensitivity analysis the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of 30,000€/QALY.

Monte-Carlo Simulation to Estimate the Health Care Costs Avoided With Fluticasone Furoate/Vilanterol Due to Exacerbation Rate Reduction in Spanish COPD Patients

analysis was performed on real-world observational data from the years 2010-2013 in The Netherlands. Data on use and adherence was collected, in patients who were dispensed bupropion or varenicline in community pharmacies for the first time. Adherence was defined a using minimal 80% of the in guidelines recommended duration and intensity of use. Results: The study cohort consisted of 4,412 users of pSCT. The number of prescriptions was stable at 0.5 prescriptions per 1,000 inhabitants (dispensing prevalence, dp) during 2010. The prevalence was on average 0.8 dp, with peaks in the the 1st and 4th quarters of 2011. In 2012, the prevalence was stable at 0.4 dp. In 2013 was on average 0.5 dp, with a small peak in the 1st quarter. Adherence was 18% in 2010 and 2012 (non-reimbursement period), and 21% in 2011 and 2013 (reimbursement period). ConClusions: Not only the likelihood of starting smoking cessation, but also the extent of adherence to pharmacologic smoking cessation is higher during reimbursement. Increasing the awareness of health care providers on adherence issues is warranted.

Economic impact of severe asthma in Spain: multicentre observational longitudinal study

Abstract Objective: Estimate the economic impact of severe asthma from the Spanish social perspective through the estimation of the associated annual direct and indirect costs. Methods: Observational, longitudinal, retrospective study carried out in 20 Spanish secondary settings (Pulmonology and Allergy Services) among patients aged ≥18, diagnosed with severe asthma according to European Respiratory Society/American Thoracic Society consensus and who have not experienced an exacerbation in the previous 2 months. Asthma-related healthcare resource utilization as well as asthma-related days off work were collected over a retrospective 12-month period from medical records review (inclusion period: June to November 2016). Total costs were calculated by multiplying the natural resource units used within 1 year by the corresponding unit cost. Costs were expressed in Euros for 2018. Results: A total of 303 patients were included, mean age was 54 years old and 67% were women. There were 5.7 physician visits per patient (3.3 in secondary care). The most common pharmacologic treatment was fixed dose combination of inhaled corticosteroids/long-acting β2-adrenergic agonists (96.7%), followed by leukotriene receptor antagonists (57.1%). 134 patients (44.2%) had at least one severe asthma exacerbation (mean: 1.9 exacerbation/patient), of whom 22 patients required hospitalization, with a mean hospital stay of 10.9 days/patient. Mean sick leave due to severe asthma was 9.1 days per patient per year. Mean annual direct cost (confidence interval 95%) was €7472/patient (€6578–8612). The cost per exacerbation was €1410/patient. When indirect costs were added (€1082/patient [€564–1987]), the total annual mean cost rose to €8554/patient (€7411–10199). Conclusions: Taking the social perspective, the economic impact of severe asthma in Spain was estimated to be €8554/patient/year.

Eficiencia de la combinación dutasterida y tamsulosina para el tratamiento de la hiperplasia benigna de próstata en España

ResumenObjetivos:Comparar la eficiencia del tratamiento de inicio con la combinación de tamsulosina y dutasterida (TAM+DUT) frente a la pauta habitual de tratamiento consistente en iniciar con TAM y a los 6 meses añadir DUT (retraso de inicio), en pacientes con hiperplasia benigna de próstata (HBP) moderada-grave con riesgo de progresión. Material y métodos: Se diseñó un modelo de Markov con un horizonte temporal a 4 años desde la perspectiva del Sistema Nacional de Salud (SNS) a partir del estudio CombAT y de los resultados del estudio de Naslund y cols. Los resultados en salud se expresaron en porcentaje de complicaciones (retención aguda de orina y cirugía). El uso de recursos sanitarios se obtuvo de un panel de expertos. Los costes unitarios (€ de 2010) proceden de las tarifas publicadas por las Comunidades Autónomas. El coste del tratamiento farmacológico se expresa en PVP-IVA. Resultados: El inicio del tratamiento con TAM+DUT es un tratamiento eficiente y dominante respecto al retraso en el inicio de la combinación al disminuir en un 15% la probabilidad de sufrir una complicación y reducir los costes sanitarios directos asociados a los 4 años. Conclusiones: El tratamiento de inicio con la combinación TAM+DUT resulta ser una alternativa de tratamiento más eficiente para el SNS que la pauta habitual de retrasar el inicio de la combinación. La adopción de tratamientos más eficientes ayudaría a aumentar la eficiencia del SNS.AbstractObjectives: To evaluate the efficiency of combination therapy with tamsulosin and dutasteride (TAM+DUT) as an initial therapy versus the common practice of starting treatment with TAM and at month 6 add DUT (delayed onset), in patients with moderate to severe benign prostate hyperplasia (BPH) with risk of progression. Methods: A Markov model was developed using a 4-year horizon and from the Spanish National Healthcare Service (NHS) perspective. Data were obtained from CombAT and Naslund et al. trials. Health outcomes were expressed as percentage of complications (acute urinary retention and surgery). Health care resources were defined by an experts’ panel, and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in final retail price. Costs are expressed in €2010. Results: Initial treatment with TAM+DUT is an efficient pattern of treatment compared with delaying the onset of combination therapy, by reducing in 15% the probability of having a complication with lower health care costs associated at 4 years. Conclusions: Starting treatment with TAM+DUT is a more efficient pattern of treatment than the common practice of delaying the onset of a combination therapy. The adoption of more efficient treatments could help to improve the efficiency of the Spanish NHS.